- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05279833
Systematic Review and Meta-Analysis of Multaq® for Safety in Atrial Fibrillation
January 5, 2024 updated by: Sanofi
SLR/NMA of Multaq® vs Sotalol to Assess for Safety in Patients With Atrial Fibrillation (AFib)
A systematic literature review (SLR) will be conducted to understand the landscape of evidence on the relative safety and effectiveness/efficacy of dronedarone compared to sotalol in patients with AFib within interventional clinical trials and observational studies.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
87810
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Chilly-Mazarin, France, 91380
- Sanofi-Aventis, France
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adults with AFib (non-permanent, including paroxysmal or persistent, long-standing persistent AFib [over 12 months])
Description
Inclusion Criteria:
Following eligibility criteria are defined to select relevant studies from the literature
- Adults with Atrial Fibrillation(AFib) (non-permanent, including paroxysmal or persistent, long-standing persistent AFib [over 12 months]))
- Participants have received either Dronedarone or Sotalol
- controlled clinical trials or comparative observational studies( prospective/retrospective cohort, case-control studies, population-based studies or registry based studies
Exclusion Criteria:
Exclusion criteria for potential participants are:
- Children/adolescents
- Permanent atrial fibrillation (AFib)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with Cardiovascular (CV) hospitalization
Time Frame: As reported in studies included in the systematic review up to 10 years
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CV hospitalization is defined as composite of heart failure hospitalization, AFib hospitalization, MI, and stroke
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As reported in studies included in the systematic review up to 10 years
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Number of participants with ventricular proarrhythmia
Time Frame: As reported in studies included in the systematic review up to 10 years
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As reported in studies included in the systematic review up to 10 years
|
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Number of all-cause mortality events
Time Frame: As reported in studies included in the systematic review up to 10 years
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As reported in studies included in the systematic review up to 10 years
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Number of cardiovascular mortality events
Time Frame: As reported in studies included in the systematic review up to 10 years
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includes arrhythmia-related mortality
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As reported in studies included in the systematic review up to 10 years
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Number of participants with atrial fibrillation (AFib) recurrence
Time Frame: As reported in studies included in the systematic review up to 10 years
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As reported in studies included in the systematic review up to 10 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with myocardial infarction
Time Frame: As reported in studies included in the systematic review up to 10 years
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As reported in studies included in the systematic review up to 10 years
|
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Number of participants with stroke
Time Frame: As reported in studies included in the systematic review up to 10 years
|
As reported in studies included in the systematic review up to 10 years
|
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Number of participants with heart failure hospitalization
Time Frame: As reported in studies included in the systematic review up to 10 years
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As reported in studies included in the systematic review up to 10 years
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Number of participants with AFib hospitalization
Time Frame: As reported in studies included in the systematic review up to 10 years
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As reported in studies included in the systematic review up to 10 years
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Number of participants with conduction disorders
Time Frame: As reported in studies included in the systematic review up to 10 years
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Atrioventricular block (2nd or 3rd degree) or Requirement of pacemaker implants
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As reported in studies included in the systematic review up to 10 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Sciences and Operations, Sanofi
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 24, 2021
Primary Completion (Actual)
March 31, 2022
Study Completion (Actual)
March 31, 2022
Study Registration Dates
First Submitted
February 17, 2022
First Submitted That Met QC Criteria
March 14, 2022
First Posted (Actual)
March 15, 2022
Study Record Updates
Last Update Posted (Actual)
January 9, 2024
Last Update Submitted That Met QC Criteria
January 5, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Arrhythmias, Cardiac
- Atrial Fibrillation
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Sympatholytics
- Sotalol
- Dronedarone
Other Study ID Numbers
- CSA0010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications.
Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.
Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Ablacon, Inc.RecruitingAtrial Fibrillation | Arrhythmias, Cardiac | Arrhythmia | Atrial Flutter | Atrial Fibrillation, Persistent | Atrial Tachycardia | Atrial Arrhythmia | Atrial Fibrillation Paroxysmal | Atrial Fibrillation, Paroxysmal or PersistentUnited States, Belgium, Netherlands, Czechia
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Maastricht University Medical CenterRWTH Aachen UniversityUnknownAtrial Fibrillation (Paroxysmal) | Atrial Fibrillation Recurrent | Atrial Fibrillation Common Gene VariantsNetherlands
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Adagio MedicalRecruitingAtrial Fibrillation | Atrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationNetherlands, Germany, Belgium
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Vivek ReddyEnrolling by invitationAtrial Fibrillation and Flutter | Atrial Flutter Typical | Atrial Fibrillation, Paroxysmal or PersistentUnited States
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R-PharmFSBI "National Medical Research Center of Cardiology named after academician...CompletedAtrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationRussian Federation
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SanofiCompletedAtrial FibrillationFrance, Poland, Italy, Netherlands, Spain, Sweden, Switzerland, Belgium, Czech Republic
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SanofiCompleted
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SanofiCompletedAtrial Fibrillation | Atrial FlutterFrance, Poland, Germany, Italy, Netherlands, Spain, Belgium, Czech Republic, United Kingdom, Denmark, Finland, Hungary